GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)— 510(k) K901854

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K901854 for GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412), Substantially Equivalent on 1990-07-09. Applicant: Amersham Corp..

Clearance details

Applicant: Amersham Corp.
Product code: Code KGI
Advisory panel: Radiology
Date received: 1990-04-24
Decision date: 1990-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.